The Drug Approval Process. An Overview

• Author: Kenneth L. Dorsney
• Pages: 29-35

29

chapter 2

The Drug Approval

Process—An Overview

A drug sponsor must obtain the Food and Drug Administration’s (FDA)

approval of a new drug application (NDA) prior to marketing a new phar-

maceutical1 in the United States.2 To obtain FDA approval of an NDA, the

Food, Drug, and Cosmetic Act (FDCA) requires the drug sponsor to dem-

onstrate that the “methods used to manufacture the drug ‘are adequate

to preserve the drug’s identity, strength, quality, and purity’” and that

the labeling on the drug packaging is appropriate.3 Most importantly,

however, the FDCA requires the drug sponsor to set forth “substantial

evidence” that demonstrates that the drug is “effective and safe”4 for its

“intended use(s).”5 The FDCA defines “substantial evidence” as “evidence

consisting of adequate and well-controlled investigations . . . by experts

qualified by scientific training and experience to evaluate the effectiveness

of the drug involved.”6 The NDA approval process can be broken down into

(1) pre-NDA-filing activities; and (2) NDA-filing and postfiling activities.

Karen E. Keller, Shaw Keller LLP (author, first and second editions), and Gregory J.

Brodzik, Young Conaway Stargatt & Taylor LLP (author, first edition).

1. In practice, a pharmaceutical that is approved under an NDA is referred to as a

“brand” drug. Esther H. Steinhauer, Is Noerr-Pennington Immunity Still a Viable Defense

against Antitrust Claims Arising from Hatch-Waxman Litigation?, 61

FOOD & DRUG L.J. 679,

680 (2006).

2. See 21 U.S.C. § 355(b)(1) (2012).

3. Brian Porter, Stopping the Practice of Authorized Generics: Mylan’s Effort to Close

the Gaping Black Hole in the Hatch-Waxman Act, 22

J. CONTEMP. HEALTH L. & POL’Y 177,

178 (2005); see 21 U.S.C. § 355(d) (2012). The Food, Drug, and Cosmetics Act regulates the

marketing of “drugs,” defined as items that are “intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man or other animals.” 21 U.S.C. § 321(g)

(1) (2012).

4. Laba Karki, Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman

Act, Regulatory Amendments and Implications for Drug Patent Enforcement, 87

J. PAT. &

TRADEMARK OFF. SOC’Y 602, 605 (2005);

see 21 U.S.C. § 355(d).

5. Carolyne R. Hathaway et al., Looking Abroad: Clinical Drug Trials, 63

FOOD & DRUG

L.J. 673, 675 (2008); see 21 U.S.C. § 355(d).

6. 21 U.S.C. § 355(d).

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